Docket Number:
FDA-2024-D-4643
Issued by:

Guidance Issuing Office

Oncology Center of Excellence

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

This draft guidance provides recommendations to sponsors regarding the measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enroll premenopausal adults with ovaries.

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